
Regulatory Affairs Expert
1 week ago
We are seeking a highly organized and detail-oriented professional to assist in the planning, execution, and maintenance of regulatory activities for clinical trials and marketing authorisation.
- Support the submission of applications and variations for clinical trials and marketing authorisation across all pipelines.
- Conduct regulatory assessments of submission requirements based on relevant regulations and provide recommendations for improvement.
- Perform administrative tasks necessary to support regulatory activities, including document management and data entry.
- Review and provide input on regulatory documents, ensuring accuracy and completeness.
- Collaborate with internal stakeholders to identify and address regulatory risks and opportunities.
Qualifications:
- Bachelor's degree in Biological, Chemistry, or a related field.
- No prior experience required, but a strong interest in Regulatory Affairs is essential.
- Excellent analytical and problem-solving skills, with a keen attention to detail and organisational abilities.
- Proficiency in English (written and spoken) is mandatory.
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